Certain dental procedures require the administration of anesthesia to a patient, in order to either block the pain that is incurred during the dental procedure, or to make the experience more pleasant for the patient. Often, this anesthetic takes the form of a local anesthesia such as lidocaine that is administered to the patient through a syringe and needle arrangement, and is injected at the site, such as the gum area, where the procedure is to be performed. In addition to this local anesthetic, many dental procedures also involve the administration of nitrous oxide to the patient. Unlike lidocaine, nitrous oxide is gaseous in form, and is administered to the patient before and during the course of the procedure, whereas lidocaine is administered prior to the procedure. Although nitrous oxide does not benefit the patient as significantly as the lidocaine from a “pain deadening” perspective, it does help to relax the patient. As such, nitrous oxide is administered as a general anesthetic to serve as a mild anesthetic and relaxant for the patient.
A large number of anesthetics are administered to patients in gaseous form, primarily within a non-dental surgical context. To administer these anesthetic gases to a patient, a face mask is used. Examples of such masks are the patient face masks manufactured by King Systems Corporation of Noblesville, Ind., that can be viewed at www.kingsystems.com. Although such anesthesia delivery masks, and in particular the masks manufactured by King, perform very admirably, and currently constitute the state-of-the-art standard in non-dental surgical anesthesia masks, dental procedures impose certain constraints upon the use of normal anesthesia face masks, that are not often found within a non-dental surgical arena.
One constraint relates to the area in which the dental procedure is performed. As most dental procedures are performed on the teeth and gums of the patient, the dentist performing the procedure must have access to the patient's mouth. Unfortunately, most surgical anesthesia masks are sized and configured to cover both the nose and mouth of the patient. As such, the use of a typically sized anesthesia mask on a dental patient prevents the dentist from obtaining access to the patient's mouth, unless the mask is removed.
Another constraint imposed by dental procedures is the requirement that the anesthesia mask be affixed to the patient for substantially the entire procedure, during which procedure the patient is usually kept awake. This requires that the dentist have some means for maintaining the mask in its proper position on the patient's face, and that the mask be secured in this position. Typically, in a non-dental surgical situation, this problem is not encountered, because an anesthesiologist is usually present. The anesthesiologist is not the person performing the surgical procedure on the patient, thus, the anesthesiologist can concentrate on placing and adjusting the mask on the patient's face in a proper position during the surgery without the responsibility of actually performing the surgery. Additionally, as the patient is usually fully “anaesthetized” during non-dental surgery, the patient is not inclined to move around during the surgery, making it easier to keep the mask in a fixed position.
Typically, during a non-dental surgical procedure, the anesthesiologist will hold the mask over the patient's nose and mouth for a sufficient time for the anesthesia to take effect. After the anesthesia has taken effect, the mask is removed from the anesthesia gas feed line, and replaced with an intubation tube, that extends down the patient's windpipe. The intubation tube may be securely attached to the patient by taping it to his face. This option is not available in most dental procedures, as the patient is not fully anaesthetized, thus making intubation an impractical alternative. As such, there is a need, during dental procedures, to employ some device for securing the mask in its proper position on the patient's face in a manner that frees the dentist's hands to perform the procedure.
Another constraint imposed by dental procedures is the requirement that the anesthesia mask be somewhat comfortable when affixed to the patient. Comfort is important because the mask is attached to the patient for substantially the entire procedure and the patient is usually kept awake during the procedure. In a non-dental procedure in which the patient is unconscious or the mask is not used for the entire procedure, it is not as important that the mask be comfortable on the patient, especially for any extended period of time.
Another complication in dental procedures relates to patient safety. Since the dental procedure often involves cutting, suturing and drilling, it is not unusual that human body fluids, (i.e. blood and saliva) and non-fluid items such as suture needles, tissue fragments, and dental materials will either become airborne or will be moving in close proximity to the eyes of the patient. In order to protect the patient's eyes, dentists heretofore have employed protective glasses to protect the eyes of patients. However, room for improvement exists in providing such eye protection, since these are difficult to wear and produce gas leaks with the current mask systems.
Because of these complications involving the administration of dental anesthetics, special masks that are adapted to dental procedures have been designed, and are in use. However, room for improvement exists regarding these known products. One area in which there exists a need for improvement relates to the containment of nitrous oxide within the dental surgical theater.
According to the American Dental Association, nitrous oxide, mixed with oxygen can be used in dental practices as a safe and effective method of managing pain and anxiety during dental procedures. Nitrous oxide usage benefits both the patient and the dental team members by providing a more comfortable visit with reduced patient stress. Using nitrous oxide sedation has few disadvantages to the patient. For the patient, the most significant potential hazard is hypoxia, although training in the administration of nitrous oxide can reduce the potential for this condition.
However, recent studies suggest that there exists the potential for hazards, due not to any one time exposure to nitrous oxide, but rather to frequent exposures to the gas on a long term basis. In particular, some studies suggest that women of child-bearing years, who are, or may become pregnant, may be affected adversely by long-term, frequent exposures to nitrous oxide.
In 1994, an article in the American Dental Association Journal discussed the use of nitrous oxide in dental practices. The ADA guidelines recommend nitrous oxide concentrations be maintained at or below 50 ppm. The committee that reviewed the nitrous oxide usage made five recommendations to the American Dental Association. One recommendation was that a better scavenger system be developed, to scavenge nitrous oxide that is administered to the patient, to better prevent the nitrous oxide from becoming resident within the dental surgical theater, where it could affect the dentist, hygienist, and other dental staff within the theater. A second suggestion was that a better nitrous oxide delivery system be designed.
The Applicant believes that the delivery and scavenger systems are extremely important in utilizing nitrous oxide. An important reason that these delivery and scavenger systems are important is that the primary persons at risk from, long-term, frequent exposure to nitrous oxide are women of child-bearing age. Such persons are frequently performing dental procedures, as the majority of dental assistants are female, and are between the age of 18 and 38 and a large number of dentists are female. These females, who are most likely to be exposed to frequent, long-term intervals of nitrous oxide, are the very people who are at greatest risk of being affected adversely by nitrous oxide. In this regard, some studies suggested that there exists an increased risk for spontaneous abortion with increased exposure to nitrous oxide. This increased risk leads many dentists to decline to use nitrous oxide in their practice.
Another concern relating to dental procedures relates to the use of eye protection. Although safety glasses are used throughout dentistry, the use of safety glasses or eye protection is becoming more wide-spread in other medical and dental specialties. This need for eye protection is highlighted by a case wherein a malpractice suit was brought against an orthodontist. It involved a wire injuring a patient. The particular wire was allegedly being bent by the orthodontist, popped out of his hands, and flew over multiple chairs, to land in a patient's eye, allegedly damaging the patient's eye. To avoid such injuries occurring to patients, and to reduce the risk of malpractice, many dentists, orthodontists and others have made the use of safety glasses routine procedure within their practice. Unfortunately, the use of safety glasses induces difficulties with nitrous oxide mask delivery and leakage.
Another concern relates to the comfort of the mask for the patient. Since the anesthesia mask is attached to the patient for substantially the entire procedure and the patient is usually kept awake during the procedure, it is preferable that the mask be somewhat comfortable when affixed to the patient. Several of the currently used dental masks are somewhat heavy and rigid, and are opaque. They also can have a plastic or rubber smell which can be unpleasant for the patient. These factors can induce a restricted, claustrophobic and otherwise uncomfortable feeling for the patient.
Due to these concerns expressed above, the Applicant sought to provide an improved dental mask that better isolates the nitrous oxide being delivered to the patient from the dental assistants and dentists performing a procedure. Additionally, in the preferred embodiment of the present invention, it is also an object of the present invention to provide an eye protection mechanism to increase patient safety; that can be securely coupled to a patient's head during the dental procedure in a manner that retains the mask in its desired position throughout the dental procedure and that is more comfortable for the patient.